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Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008, ISSN 0974-3618
www.rjptonline.org
RESEARCH ARTICLE
Formulation and Evaluation of Sustained Release Matrix Tablet of Anti-Anginal
Drug, Influence of Combination of Hydrophobic and Hydrophlic Matrix Former
SH Lakade* and MR Bhalekar
Sinhgad College of Pharmacy Lonavala Pune-411401, AISSMS college of Pharmacy, Kennedy Road Pune. *Corresponding Author E-mail: sameer_patil97@rediffmail.com

ABSTRACT

Most of the conventional drug delivery system for treating the anginal are not much effective as the drug do not reach the
site of action in appropriate concentration. Thus an effective and safe therapy of this anginal disorder using specific drug
delivery system is a challenging task to the pharmaceutical technologists. The objective of the present study was to
develop hydrophilic polymer (HPMC) and hydrophobic polymer (Ethyl cellulose) based Nicorandil matrix sustained
release tablet which can release the drug up to time of 24 hrs in predetermined rate. The formulation of Nicorandil matrix
tablet was prepared by the polymer combination in order to get required theoretical release profile. The influence of
hydrophilic and hydrophobic polymer and granulation technique on Nicorandil was studied. The formulated tablet were
also characterized by physical and chemical parameters, The in-vitro release rate profile should the higher concentration
of F2 polymer in tablet, the combination of hydrophilic and hydrophobic combination showed less result than use of
alone. The in–vitro release data was well fit to Peppas and Hixon crowel release kinetics.

KEY WORDS

Nicorandil, Water insoluble, Matrix tablet, Hydrophobic, Hydrophilic, Polymer.
INTRODUCTION:

Angina and hypertension are the most common Hence in the present study work an attempt has been made cardiovascular diseases. For the angina and to develop sustained release matrix tablet of Nicorandil hypertension potassium channel openers are presently using hydrophobic and hydrophilic polymers. Matrix most important class of drug. The first therapeutic drug material such as (HPMC) hydroxyl propyl methyl cellulose shown to posses and ability to hyperpolarize smooth and ethyl cellulose, Pvp, Gaur gum, Xanthan gum4. The muscle cell membrane is Nicorandil is one of the drug release for extended duration, particularly for highly emerging molecules in case of angina, successful water soluble drug using a hydrophilic matrix system is treatment means maintenance of blood pressure at restricted because of the rapid diffusion of the dissolved normal physiological level, for which a constant and drug though the hydrophilic network5. For such drug with uniform supply of drug is desired. This drug has short high water solubility hydrophobic polymers are suitable, half life of 1hrs and the calculated sustained release along with a hydrophilic matrix for developing sustained dose of Nicorandil is 40 mg taken twice in a day release dosage forms6. Therefore in this study both the times1. To reduce the administered dose and to improve hydrophilic and hydrophobic polymer was used as matrix patient convenience and compliance, a sustained material. The main objective of the study is to formulate release matrix tablet formulation of Nicorandil is several hydrophilic and hydrophobic matrix systems by desirable2. The drug is freely soluble in water and polymer material to investigate the effect of both7. hence selections of both hydrophobic and hydrophilic polymer matrix system are widely used in oral MATERIALS AND METHODS:
controlled drug delivery to obtain a desirable drug HPMC, Ethyl cellulose, Gaur gum, Zanthan gum, Pvp, release, patient compliance and cost–effectiveness3. Magnesium starate, Talc, all the ingredients used were of Formulation of tablets: Formation of Nicorandil matrix
tablet were prepared by wet granulation method. For these all the powders were passed through 80 mesh8. Drug and Received on 08.08.2008 Modified on 10.09.2008 polymer were mixed thoroughly with including granulating Accepted on 10.10.2008 RJPT All right reserved agent, after mass of cohesive material was sieved through Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008;Page 410-413 22 and 44 mesh9. Afterwards the granules dried at 40oc for Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008, Table No:-1 Formulation of Nicorandil Sustained Release Matrix Tablet

Table No:-2 Evaluation
of Nicorandil Sustained Release Matrix Tablet
6-12 hrs, then talc and magnesium starate were added. Figure No: 1 Comparative Dissolution Profile of Nicorandil
Finally the tablets were compressed using single punch sustained release matrix tablet
machine, tablet compression machine 11mm punch In-Vitro Dissolution Study:
The study was carried out using 0.1NHcl and phosphate buffer 7.4 using the USP apparatus types II, the dissolution medium 900 ml maintained at 37oc ± 0.5oc, The absorbance was measured at 262nm, the dissolution study were carried out for 24 hrs11. Evaluation of tablet blend:-
Bulk density: Apparent bulk density was determined
by placing pre-sieved drug excipient blend in to a graduated cylinder and measuring the volume and Figure No:-2 Dissolution profile of optimize batch of
Nicorandil sustained release matrix tablet

Tapped density
: Tapped density was determined by
USP method II tablet blend was filled in 100 ml graduated cylinder of tap density tester which was operated for fixed number of taps until the powder bed volume has reached a minimum, thus was calculated by Where, M = Weight of powder taken; Vb = tapped Angle of Repose: Angle of repose was determined by
using funnel method. Tablet blend were poured from funnel, that can be raised vertically until a maximum Compressibility index and Hausner ratio:
cone height h was obtained diameter heap D, was This was measured for the property of a powder to be measured. The repose angle q was calculated by compressed; as such they are measured for relative importance of interparticulate interactions. Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008, Compressibility index was calculated by following is 5%. The average percentage deviation of all tablet formulation was found to be within the pharmacopoeial Compressibility index = ⎨(Dt –Db)⎬ x 100 limit and hence all formulation passed the test for Where, Dt = tapped density; Db = bulk density; uniformity of weight. The friability of all formulation was below the 1% limit shown in the pharmacopoeia indicating Hausner ratio was calculated by following equation that the friability is within the standard limit. The result of the dissolution study indicating that F1, F2 released 9.3, Where, Dt = tapped density; Do = bulk density14 5.71, of Nicorandil at the end of 2hrs and 84.56, 73.82 at end of 24hrs respectively, from the released pattern of first Evaluation of tablet
two formulation the 100% released was not found at the end of 24hrs, this may be due to the hardness of the tablet. Weight variation: Twenty tablets were randomly
Formulation F4, F5, F6 released 7.33, 9.21, 7.81 at the end selected from each batch individually weigh, the of 2hrs and 76.87, 86.18, and 90.97 at the end of 24hrs; the average weight and standard deviation of 20 tablet released rate of Nicorandil was comparatively higher than first two formulations this may be due to combination of two polymers. But this formulation containing HPMC Thickness: The thickness of the tablet was measured
released 23.48 at the end of 2 hrs and 99.97 at the end of 24 by using digital venire caliper, twenty tablet from each hrs alone this could indicate that the drug– polymer 1:4 batch were randomly selected and thickness were ratio released the drug from matrix and this ratio fits for the matrix sustained released tablet of Nicorandil. The formulation F4, F5, F6 is the combination of the two Hardness: Hardness was measured using Pfizer
polymers with incorporating 10% (20mg) of PVP hardness tester, for each batch three tablet were (Polyvinyl pyrolidon) in the formulation. The formulation F7, F8, F9 are also the combination of two polymer and incorporation of ethyl cellulose in the formulation, F7, F8, Friability: Twenty tablets were weight and placed in
F9 released 2.13, 3.18, and 3.12 at the end of 2hrs and the Roche friabilator and apparatus was rotetted at 25 9.71, 70.10, and 71.13 at the end of 24hrs. Formulation F7, rpm for 4 min. After revolution the tablets were dusted F8 and F9 showed less released compared to the formulation F4, F5, F6 this could be due to the presence of ethyl cellulose which is generally responsible for the hardness of Drug content uniformity: The drug content was
the tablet low hardness value obtained in the formulation determined by taking an accurately weight amount of F3, F2, F1 this may be due to addition of Pvp and ethyl powdered Nicorandil 100 mg with water and solution was filtered through 45µ membrane. The absorbance was measured at 262 nm, using double beam uv visible ACKNOWLEDGEMENTS:
The author would like to sincerely gratitude to the Laben laboratories Akola, Maharashatra, for providing all RESULTS AND DISCUSSION:
Initially tablet were prepared with drug to polymer ratio 1:1 with pvp and ethyl cellulose but the tablet REFERENCES:
released 100% of drug within 4 hrs and the tablet Chandran S, Punnarao R and Shah R. Development and In- prepared with drug to polymer ratio 1:2 and 1:3 vitro Evaluation of oral controlled release formulations of released 100% Nicorandil at 11 hrs and hence drug Celecoxib using optimization techniques. J. Pharm. Sci. polymer ratio1:1, 1:2, 1:3, was not selected and hence drug polymer ratio 1:4 was selected. The granules of Efentakis M, Ronald DC and Sonel MT. Development and various formulation were prepared and evaluated for Evaluation of oral multiple unite and single unite angle of repose, ranged from 22.30 ± 0.01 to 27.63 ± hydrophilic controlled–release system. Pharm. Sci. Tech. 0.03. The bulk density of granules using pvp 10% Dekker SM, Decardo PT and Robert AC. Formulation of alcoholic solution was found to be 13.12-14.84.The sustained release lithium carbonate matrix tablet influence of drug content of weight amount of granules of all hydrophilic matrix tablet influence of hydrophilic materials in formulation were found to be in a ranged from 38 ± the release and in-vitro in-vivo evaluation. J. Pharm. Sci. 0.65 to 75 ±1.03. The thickness of tablet was carried out for all batches were found consistent. The tablets of Roddin AT, Fedderer OS and Frenklin CK. Formulation and various batches formulated were evaluated for test such Evaluation of extended release matrix tablet of zidovudin, as hardness, friability and drug content, thickness, influence of combination of hydrophilic and hydrophobic uniformity of weight. The weight variation tests were matrix former. Pharm. Sci. Tech. 2001; 7(4): 1-8 Karlos NN and Ostin PC. In-vitro-studies of diclofenac performed according to the procedure given in the sodium controlled release from biopolymeric hydrophillic pharmacopoeia. In a weight variation test, matrices. J. Pharm. Sci. 2003; 5(3): 213-219. pharmacopoeial limit of tablet for percentage deviation Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008, Rezal MD, Qadir MA and Haider SS. Comparative evaluation of polymers as matrix for controlled release drug delivery. J. Pharm. Pharmaceutical Sci. 2003; 6(2): 274-291 Brabander CD, Vervacet C and Remon JP. Development and evaluation of sustained release matrix tablet. J. Controlled Release. 2002; 77(1): 245-258. Rezal MD, Qadir MA and Haider SS. Comparative evaluation of polymers as matrix for controlled release drug delivery. J. Pharm. Pharmaceutical Sci. 2003; 6(2): 274-291 Andreopopulas AG and Tarantilli PA. Xanthan gum as a
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